Body Parameters as an Independent Predictor of Acute Pancreatitis
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ClinicalTrials.gov Identifier: NCT03482921 |
Recruitment Status :
Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
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Tracking Information | |||||
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First Submitted Date | March 23, 2018 | ||||
First Posted Date | March 29, 2018 | ||||
Last Update Posted Date | March 29, 2018 | ||||
Actual Study Start Date | December 1, 2017 | ||||
Actual Primary Completion Date | February 12, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Body Parameters as an Independent Predictor of Acute Pancreatitis | ||||
Official Title | Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study | ||||
Brief Summary | This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients. | ||||
Detailed Description | Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage. It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | 7 Years | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning. | ||||
Condition | Acute Pancreatitis | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
1662 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | March 22, 2018 | ||||
Actual Primary Completion Date | February 12, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03482921 | ||||
Other Study ID Numbers | Ningbo4 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Ningbo No. 1 Hospital | ||||
Study Sponsor | Ningbo No. 1 Hospital | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Ningbo No. 1 Hospital | ||||
Verification Date | March 2018 |